Company: Philips Medical Systems Nederland B.V.
Date of Enforcement Report: 9/9/2025
Class: II

PRODUCT

IntelliSpace Cardiovascular, Software 8.0.0.4.

Recall Number:

Z-2543-2025

REASON:

Software issue that results in the display of outdated information.

RECALLING FIRM/MANUFACTURER:

Philips Medical Systems Nederland B.V.

QUANTITY:

4 units

DISTRIBUTION:

US Nationwide distribution in the states of GA, NC & TX.